Clinical Research on the Effect of Different Extents of Internal Limiting Membrane Peeling on Macular Hole Closure and Visual Acuity

NCT ID: NCT03805763

Last Updated: 2019-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2020-01-31

Brief Summary

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Observing and describing the surgical effects of different extents of internal limiting membrane peeling combined with internal limiting membrane insertion for macular hole

Detailed Description

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Conditions

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Macular Holes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Large extent of ILM Peeling

Extent of ILM peeling is 4DD and the ILM flap is inserted

Group Type EXPERIMENTAL

Large extent of ILM Peeling

Intervention Type PROCEDURE

The extent of ILM peeling is 4DD

Small extent of ILM Peeling

Extent of ILM peeling is 2DD and the ILM flap is inserted

Group Type EXPERIMENTAL

Small extent of ILM Peeling

Intervention Type PROCEDURE

The extent of ILM peeling is 2DD

Interventions

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Large extent of ILM Peeling

The extent of ILM peeling is 4DD

Intervention Type PROCEDURE

Small extent of ILM Peeling

The extent of ILM peeling is 2DD

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Clear diagnosis of macular hole;
* The minimum diameter of the macular hole is \>400 μm;
* Without serious systemic disease that make patients can not be operated;

Exclusion Criteria

* suffering from severe retinal diseases such as: diabetic retinopathy, age-related macular degeneration, peripheral retinal detachment, PVR, etc.;
* opacitas in the refractive medium can not perform Angio-OCT and visual acuity examination;
* eye acute and chronic inflammation, such as acute contagious conjunctivitis, acute and chronic keratitis, acute dacryocystitis;
* traumatic macular hole, secondary macular hole, high myopia macular hole, etc.;
* having a history of vitrectomy surgery;
* glaucoma in stage of preclinical, severe stenosis or closure;
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Xiangtian Zhou

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zongduan Zhang, M.D,PhD

Role: PRINCIPAL_INVESTIGATOR

The Eye Hospital of Wenzhou Medical University

Central Contacts

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Zongduan Zhang, M.D,PhD

Role: CONTACT

+86 13587604949

Qintuo Pan, M.D

Role: CONTACT

-86 13958851073

Other Identifiers

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ZZD-Macular Hole

Identifier Type: -

Identifier Source: org_study_id

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